A Randomized Controlled Trial of Doxycycline Post Exposure Prophylaxis to Prevent Incident Bacterial STIs Among Women in the United States

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorTulane University

About this trial

The bacterial sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis cause multiple adverse outcomes in women, and prevention strategies are critically needed. This project will determine the efficacy of doxycycline post-exposure prophylaxis (doxy PEP) to prevent STIs among women through a phase IV, open-label, randomized controlled trial.

Eligibility criteria

Qualifiers

Female

Aged 18-35

diagnosis of CT, gonorrhea, syphilis, or trichomonas in the past year

reporting 2 or more sexual partners in the past 6 months

Disqualifiers

Pregnant, nursing, or intending to become pregnant

Reported allergy to tetracyclines

Liver disease or end-stage renal disease

Non-English Speaking

Trial design

Treatments tested in this trial

  • Doxycycline
  • Standard of Care (SOC)

Treatment groups

519 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Tulane University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

University of Alabama at Birmingham

Collaborator

Louisiana State University Health Sciences Center in New Orleans

Collaborator